G-TwYST Study Plans

Considerations

In a first consideration, the G-TwYST consortium intended to perform rat feeding trials with GM maize NK 603 and MON810 based on OECD Test Guidelines and according to EFSA recommendations. In autumn 2014, EFSA published an explanatory statement regarding the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed for GMO risk assessment and proposed to consider an increased inclusion rate for maize (e.g. up to 50%) rather than a standard inclusion rate of 33%. In addition, the G-TwYST Advisory Board and several stakeholders criticized the suggested chronic toxicity feeding trial with MON810, which only included one instead of typically two dosage groups because of animal housing capacity limitations and financial constraints. Moreover, several stakeholders criticized that potential toxic effects such as immunotoxicity and endocrine disruption were not taken into consideration.

Major changes

By taking into account all the above-mentioned considerations, the G-TwYST consortium took the following decisions:

to perform the original 90-day feeding trial with GM maize NK603 at an inclusion rate of 11 and 33%;

not to perform the 2-year feeding trial with the GM maize MON810*;

to perform a further 90-day feeding trial with GM maize NK603 at an inclusion rate of 50%;

to perform the original combined chronic toxicity/carcinogenicity feeding trial with GM maize NK603 at an inclusion rate of 11 and 33%;

to analyze potential immunotoxic and endocrine effects in the 90-day feeding trial with GM maize NK603 at an inclusion rate of 11 and 33%.

Written comments

Seven stakeholders representing industry, civil society, science and competent authorities filed more than 100 written comments to the G-TwYST draft study plan. Comments and responses were split in 8 categories:

*In the frame of G-TwYST it was originally planned to perform a 2-year carcinogenicity feeding trial with the GM maize MON810 at an inclusion rate of 33% on top of the 2-year study with maize NK603. Due to financial and animal housing constraints, it was not possible to include a further experimental group with an inclusion rate of e.g. 11% for the maize MON810 study. Hence, it would not have been possible to analyse a dose-effect relationship with this trial data.
Moreover, in the stakeholder consultation it was strongly recommended to include a 50% maize NK603 diet in the 90-day study with maize NK603, pushing the maize content of the diet to the limit of what is considered acceptable in terms of nutritional balance.

Given the constraints in time, lab space (the number of animals we can house at the same time) and funding we are not able to follow all recommendations, i.e. both including a 50% diet in the 90-day study and largely increasing the number of animals in a maize MON810 combined 2-year study, so we chose to focus on an approach that will ensure most robust outcomes in terms of science and statistics. The best way to achieve that is dropping the 2-year maize MON810 study and include an additional 90-day study with maize NK603 (study plan 2) with a 50% diet.

Latest news

Tomorrow‘s food: How GMOs change global farming

30 July 2018

Austrian documentary makers from the media and research platform addendum.org published a version of their documentary "Tomorrow‘s food: How GMOs change global farming" with english subtitles (put subtitles 'on') on their Youtube channel. They included the G-TwYST findings that were presented at the final Conference in Bratislava on April 16, 2018 (between 28:15 and 31:20 in the documentary).

G-TwYST Conclusions & Recommendations

29 April 2018

At a Conference held in Bratislava, Slovakia, on 16 April 2018, G-TwYST presented draft conclusions and recommendations regarding guidance on the design, conduct, interpretation, and analysis of animal feeding studies and their value for GMO risk assessment. A final version of G-TwYST Conclusions and Recommendations can be downloaded here.

GMP Two Year Safety Testing
(G-TwYST) is a Collaborative Project of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities.